Safety, Tolerability, PK, PD, ADA of Escalating Single Dose of CJ-40002 in Healthy Male Subjects (hGH)

A Dose-block Randomized, Single-blind, Placebo-controlled, Single-dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CJ-40002 After Subcutaneous Injection in Healthy Adult Male Volunteers

The objectives of this study are:

• To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy male volunteers.
• To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers.
• To evaluate the PD of CJ-40002 after single SC injection in healthy male volunteers.
• To evaluate the ADA of CJ-40002 after single SC injection in healthy male volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CJ-40002

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male volunteers in the age between 19 and 45 years old (inclusive)
• Body mass index (BMI) in the range of 18.5 to 25 kg/m2 and weighing at least 55 kg
• Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form, after having listened to the purpose, method, and effect of the clinical trial

Exclusion Criteria:

• History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition
• History of allergy or sensitivity to any drug

• Subject with the following clinically significant laboratory abnormalities:

  • AST or ALT > 1.25 x Upper Limit Normal (ULN)
  • Total bilirubin > 1.5 x Upper Limit Normal (ULN)
  • CPK > 1.5 x Upper Limit Normal (ULN)
  • eGFR < 60 mL/min/1.73 m2
• Systolic blood pressure outside the range of 90 to 150 mmHg or diastolic blood pressure outside the range of 50 to 100 mmHg
• History of drug abuse
• History of caffeine, alcohol, smoking abuse
• Participation in any clinical investigation within 60days prior to study medication dosing
• Subjects with whole blood donation within 60days, component blood donation within 30days prior to study medication dosing
• Positive test results for HBs Ab, HCV Ab, HIV test
• Subjects considered as unsuitable based on medical judgement by investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose level 1 of CJ-40002; Single dose; 8 volunteers will be administered dose level 1 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)	Drug: CJ-40002
Experimental: Dose level 2 of CJ-40002; Single dose; 8 volunteers will be administered dose level 2 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)	Drug: CJ-40002
Experimental: Dose level 3 of CJ-40002; Single dose; 8 volunteers will be administered dose level 3 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)	Drug: CJ-40002
Experimental: Dose level 4 of CJ-40002; Single dose; 8 volunteers will be administered dose level 4 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)	Drug: CJ-40002
Experimental: Dose level 5 of CJ-40002; Single dose; 8 volunteers will be administered dose level 5 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)	Drug: CJ-40002

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: AUC, Cmax	15 days
Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction)	29 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Tmax, T1/2, CL/F, Vd	15 days
Pharmacodynamics: Serum IGF-1, free IGF-1, IGFBP-3, GHBP	15 days
Formation of anti-drug antibodies	29 days

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Min Soo Park, MD, PhD, Yonsei University College of Medicine, Seoul, Korea

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (Estimate): May 26, 2014

Study Record Updates

• Last Update Posted (Estimate): December 29, 2016
• Last Update Submitted That Met QC Criteria: December 28, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CJ_HGH_101